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This medical policy (medical coverage guideline) is Copyright 2015, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2015 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-33000-25

Original Effective Date: 01/01/02

Reviewed: 05/23/13

Revised: 07/01/13

Subject: Ventricular Assist Devices and Total Artificial Hearts

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates  

DESCRIPTION:

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 survival. The U.S. Organ Procurement and Transplantation Network (OPTN) reports survival rates at 1-, 5-, and 10-years of 88%, 74%, and 55%, respectively. The supply of donor organs has leveled off, while candidates for transplants are increasing, compelling the development of mechanical devices.

The New York Heart Association (NYHA) developed a functional classification for patients with heart disease. Each of the four classifications are described in the table below:

Class I (mild)

Has no limitations on clinical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath).

Class II (mild)

Has slight limitations of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.

Class III (moderate)

Has marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.

Class IV (severe)

Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.

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.

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. 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. Ventricular assist devices are most commonly used to support the left ventricle, but right ventricular and biventricular devices may be used.

Ventricular assist devices approved by the FDA include the Abiomed AB5000™, AbioMed BVS5000™, HeartMate II®, HeartMate II LVAS®, HeartMate IP®, HeartMate SNAP VE LVAS ®, HeartMate VE LVAS®, HeartMate XVE LVAS®, HeartWare® VAS, HeartWare® Ventricular Assist System (HVAD® Pump), Novacor LVAS®, Thoratec IVAD®, Thoratec VAD System®, DeBakey VAD® Child, and the EXCOR® Pediatric VAD.

Percutaneous Ventricular Assist Devices

Percutaneous ventricular assist devices have been developed for short-term use in patients who require acute circulatory support. These devices can be placed through the femoral artery in the cardiac catheterization lab without the need for open-chest surgery. They differ from other VADs in that they use a trans-septal approach to the left atrium or left ventricle. Oxygenated blood is pumped from the left atrium into the arterial system via the femoral artery, or from the left ventricle, through the device, and into the ascending aorta, depending on which device is used. 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.

Percutaneous ventricular assist devices approved by the FDA include the Impella Recover® LP 2.5; Impella 5.0 Percutaneous Cardiac Support System, Impella CP (Cardiac Power) and the TandemHeart® PTVA® System.

Right Ventricular Assist Devices

Right ventricular assist devices are intended to provide temporary circulatory support for up to fourteen days for patients in cardiogenic shock due to acute right ventricular failure. The device is contraindicated in patients who are unable or unwilling to be treated with heparin or an appropriate alternative anticoagulation. Although right ventricular heart failure is infrequent, it may occur following cardiac surgery, myocardial infarction (MI), heart transplantation, or implantation of an LVAD. rVADs receive blood from either the right atrium or right ventricle and deliver it to the pulmonary artery, via an inflow cannula placed in either the right atrium (RA) or right ventricle.

The CentriMag® Right Ventricular Assist System (RVAS) has received FDA approval for temporary use in those individuals who have cardiogenic shock due to right sided heart failure and need temporary circulatory support (up to fourteen days).

Total Artificial Hearts

Total artificial hearts are biventricular devices which completely replace the function of the diseased heart. Initially, an internal battery required frequent recharging from an external power source. Systems now utilize a percutaneous power line, and a transcutaneous power-transfer coil allows for a system without lines traversing the skin, possibly reducing the risk of infection. Because the heart must be removed, failure of the device is synonymous with cardiac death.

The SynCardia temporary Total Artificial Heart (TAH-t) was approved by the U.S. Food and Drug Administration (FDA) in October 2004 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 intended for use inside the hospital.

The AbioCor® Total Artificial Heart (TAH) was approved by the FDA in September 2006 through the Humanitarian Device Exemption (HDE) process for use in severe biventricular end-stage heart disease individuals who are not cardiac transplant candidates. The AbioCor® Total Artificial Heart (TAH) is fully implantable and is intended for heart failure patients who are at risk of imminent death. It is intended as a permanent cardiac replacement. 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.

POSITION STATEMENT:

The use of an FDA-approved or cleared implantable left ventricular assist device (VAD) meets the definition of medical necessity:

• As a bridge to heart transplantation for:

o Members who are currently listed as heart transplant candidates, or are undergoing evaluation to determine candidacy for heart transplant, and are not expected to survive until a donor heart can be obtained; OR

o Members with biventricular failure who:

- Have no other reasonable medical or surgical treatment options, AND

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

- Are currently listed as heart transplant candidates; AND

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

• As a bridge to recovery in the post-cardiotomy setting in members who are unable to be weaned off cardiopulmonary bypass.

• As destination therapy with end-stage heart failure in members who are ineligible for human heart transplant and who meet the following criteria:

o New York Heart Association (NYHA) class IV heart failure for ≥ 60 days, OR

o NYHA class III/IV heart failure for at least 28 days AND

- Received ≥14 days support with intra-aortic balloon pump (IABP), OR

- Dependent on IV inotropic agents, with 2 failed weaning attempts.

• In addition, ineligibility for human heart transplant must be for 1 or more of the following reasons:

o Age >65 years; OR

o Insulin dependent diabetes mellitus with end-organ damage; OR

o Chronic renal failure (serum creatinine >2.5 mg/dL for ≥90 days); OR

o Presence of other clinically significant condition.

The use of an FDA-approved or cleared percutaneous ventricular assist device meets the definition of medical necessity:

• To provide short-term circulatory support for patients with cardiogenic shock.

The use of an FDA-approved or cleared right ventricular assist device meets the definition of medical necessity when both of the following are met:

• Device is used for temporary circulatory support for up to fourteen days for individuals in cardiogenic shock due to acute right ventricular failure; AND

• Member is willing and able to be treated with heparin or an appropriate alternative anticoagulation.

The use of the SynCardia temporary Total Artificial Heart (TAH-t) as a bridge to transplantation meets the definition of medical necessity when all of the following are met:

• Biventricular failure with no other reasonable medical or surgical treatment options; AND

• Ineligible for other univentricular or biventricular support devices; AND

• Currently listed a heart transplant candidate or undergoing evaluation to determine candidacy for heart transplant; AND

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

Other applications of left ventricular devices or total artificial hearts are considered experimental or investigational, as there is insufficient clinical evidence to allow conclusions on health outcomes, specifically for, but not limited to, the use of total artificial hearts as destination therapy. The use of non-FDA approved or cleared implantable ventricular assist devices or total artificial hearts is considered experimental or investigational.

BILLING/CODING INFORMATION:

CPT Coding:

33975

Insertion of ventricular assist device; extracorporeal, single ventricular

33976

Insertion of ventricular assist device; extracorporeal, biventricular

33977

Removal of ventricular assist device; extracorporeal single ventricular

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

0051T

Implantation of a total replacement heart system (artificial heart) with recipient cardiectomy

0052T

Replacement or repair of thoracic unit of a total replacement heart system (artificial heart)

0053T

Replacement or repair of implantable component or components of total replacement heart system (artificial heart), excluding thoracic unit

ICD-9 Diagnoses Codes That Support Medical Necessity:

398.91

Rheumatic heart failure (congestive)

402.01

Malignant hypertensive heart disease with congestive heart failure

402.11

Benign hypertensive heart disease with congestive heart failure

404.01

Malignant hypertensive heart and renal disease with congestive heart failure

404.03

Malignant hypertensive heart and renal disease with congestive heart failure and renal failure

404.11

Hypertensive heart and renal disease with congestive heart failure and renal failure

428.0

Congestive heart failure, unspecified

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

I09.81

Rheumatic heart failure

I11.0

Hypertensive heart disease with heart failure

I13.0 – I13.2

Hypertensive heart and chronic kidney disease

I50.20

Unspecified systolic (congestive) heart failure

I50.30

Unspecified diastolic (congestive) heart failure

I50.40

Unspecified combined systolic (congestive) and diastolic (congestive) heart failure

I50.9

Heart failure, unspecified

REIMBURSEMENT INFORMATION:

Removal of the device prior to heart transplantation is considered part of the global fee and is incidental to the heart transplant procedure.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: The following National Coverage Determination (NCD) was reviewed on the last guideline revised date: Artificial Hearts and Related Devices (20.9) located at cms.gov.

DEFINITIONS:

Destination therapy: the use of a ventricular assist device (VAD) for long-term, permanent support in patients who are not candidates for transplant.

Humanitarian Device Exemption: a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 people in the United States per year.

Inotropic support: medications to help the heart pump more effectively.

Intra-aortic balloon pump: a machine that helps the heart pump; a catheter threaded into the aorta is equipped with a tip that helps pump blood out of the heart; does not require open chest surgery for placement.

RELATED GUIDELINES:

Heart Transplant, 02-33000-23
Heart and Lung transplant, 02-33000-24

OTHER:

None Applicable.

REFERENCES:

  1. All-Plan Survey (Blue Cross Blue Shield), (11/99).
  2. American College of Cardiology. "ACC/AHA Guidelines for the Evaluation and Management of Heart Failure." Published 2001; accessed 05/29/07.
  3. American Medical Association CPT Coding (current edition).
  4. Blue Cross Blue Shield Association Medical Policy Reference Manual. 7.03.08 Heart/Lung Transplant, (04/25/06).
  5. Blue Cross Blue Shield Association Medical Policy Reference Manual. 7.03.11 Ventricular Assist Devices and total Artificial Hearts. (February 2013). Accessed 05/01/13.
  6. Blue Cross Blue Shield Association TEC Assessments 1996, 2002.
  7. Centers for Medicare & Medicaid Services (CMS) National Coverage Determination for Artificial Hearts and Related Devices, Publication #100-3, Section 20.9 (11/09/10). Accessed 05/01/13.
  8. Centers for Medicare and Medicaid Services (CMS) Decision Memo for Ventricular Assist Devices as Destination Therapy (CAG-00119N); 10/01/03.
  9. Centers for Medicare and Medicaid Services (CMS) Decision Memo for Artificial Hearts (CAG-00322N); 05/01/08.
  10. Cheng JM, Corstiaan A, Hoeks SE, van der Ent M, Jewbali LSD, van Domburg RT, Serruys PW. Percutaneous left ventricular assist devices vs. intra-aortic balloon pump counterpulsation for treatment of cardiogenic shock: a meta-analysis of controlled trials. European Heart Journal (2009) 30, 2102–2108.
  11. Clinical Trials.gov. Abiocor Implantable Replacement Heart. Verified by Abiomed Inc., April 2008. Identifier: NCT00669357.
  12. ClinicalTrials.gov. SynCardia CardioWest TAH-t Postmarket Surveillance Study. Sponsored by SynCardia. Identifier: NCT00614510.
  13. ClinicalTrials.gov. NCT01415869. Occult Gastrointestinal Bleeding in Non-pulsatile Left Ventricular Assist Device (VAD) Patients. Last Updated on 08/08/11 by Mayo Clinic.
  14. ClinicalTrials.gov. NCT01185691. Investigating the Role of Impella 2.5 System in Acutely Decompensated Chronic Heart Failure Patients (RELIEF I). Last Updated on March 18, 2011 by Abiomed, Inc.
  15. ClinicalTrials.gov. NCT01319760: MINI-AMI: Minimizing Infarct Size With Impella 2.5 Following PCI for Acute Myocardial Infarction. Accessed on 04/26/13.
  16. ClinicalTrials.gov. NCT00972270: Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation (PERMIT1). Accessed on 04/26/13.
  17. ClinicalTrials.gov. NCT00972270: Trial Using Impella LP 2.5 System in Patients With Acute Myocardial Infarction Induced Hemodynamic Instability (RECOVER II). Accessed on 04/26/13.
  18. ClinicalTrials.gov. NCT00314847: Comparison of Standard Treatment Versus Standard Treatment Plus Extracorporeal Life Support (ECLS) in Myocardial Infarction Complicated With Cardiogenic Shock. Accessed on 04/26/13.
  19. ClinicalTrials.gov. NCT01633502: Danish Cardiogenic Shock Trial (DanShock). Accessed on 04/26/13.
  20. ClinicalTrials.gov. NCT01185691: Investigating the Role of Impella 2.5 System in Acutely Decompensated Chronic Heart Failure Patients (RELIEF I). Accessed on 04/26/13.
  21. ClinicalTrials.gov. NCT01777607: The Use of Impella RP Support System in Patients With Right Heart Failure. Accessed on 04/26/13.
  22. ClinicalTrials.gov. NCT00596726: RECOVER I Impella RECOVER LP/LD 5.0 Support System Safety and Feasibility Study. Accessed on 04/26/13.
  23. ClinicalTrials.gov. NCT00562016: Protect II, A Prospective, Multicenter Randomized Controlled Trial (PROTECT II). Accessed on 04/26/13.
  24. ClinicalTrials.gov. NCT00417378: Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock (ISAR-SHOCK). Accessed on 04/26/13.
  25. ClinicalTrials.gov. NCT00534859: PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI. Accessed on 04/26/13.
  26. Cubeddu RJ, MD, Lago R, Horvath SA, Vignola PA, O’Neill W, Palacios IF. Expert Review: Use of the Impella 2.5 system alone, after and in combination with an intra-aortic balloon pump in patients with cardiogenic shock: case description and review of the literature. EuroIntervention 2012; 7:1453-1460.
  27. ECRI. Target Database Report: Magnetically levitated ventricular assist device (VAD) as a bridge to decision. Plymouth meeting PA: ECRI, (11/07).
  28. ECRI. Target Database Report: Permanent Total Artificial Heart for Irreversible Heart Failure Plymouth meeting PA: ECRI, (06/04).
  29. ECRI. Target Database Report: Permanent Total Artificial Heart (TAH) for Irreversible Heart Failure Plymouth meeting PA: ECRI, (02/08).
  30. ECRI. Target Database Report: Total Artificial Heart as Bridge to Transplantation. Plymouth meeting PA: ECRI (01/07) Updated 02/06/07.
  31. ECRI. Target Database Report: Ventricular assist devices as destination therapy for irreversible heart failure. Plymouth meeting PA: ECRI (11/03).
  32. ECRI. Target Database Report: Ventricular Assist Devices for Heart Failure (long-term to heart transplant) Plymouth meeting PA: ECRI, (02/00).
  33. ECRI. Target Database Report: Ventricular Assist Devices for Heart Failure (short-term bridge to recovery) Plymouth meeting PA: ECRI, (03/00).
  34. ECRI Institute Emerging Technology Evidence Report: Total Artificial Heart as Bridge to Transplantation and Destination Therapy. December 2012.
  35. ECRI Institute Emerging Technology Report: Miniature Intracardiac Pump for Acute Heart Failure. January 2012.
  36. ECRI Institute Health Technology Forecast: More data presented at ACC confirm miniature heart pump failed to meet primary endpoints in trial. April 2011.
  37. Edoardo Gronda, MD, Robert C. Bourge, MD, Maria Rosa Costanzo, MD, Mario Deng, MD, Donna Mancini, MD, Luigi Martinelli, MD, and Guillermo Torre-Amione, MD. Heart Rhythm Considerations in Heart Transplant Candidates and Considerations for Ventricular Assist Devices: International Society for Heart and Lung Transplantation Guidelines for the Care of Cardiac Transplant Candidates – 2006. The Journal of Heart and Lung Transplantation. Volume 25, Issue 9, pages 1024 – 1042. September 2006.
  38. Glenn N 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:e574-e651.
  39. Gregory D et al. A Value-Based Analysis of Hemodynamic Support Strategies for High-Risk Heart Failure Patients Undergoing a Percutaneous Coronary Intervention. Am Health Drug Benefits. 2013;6(2):88-99.
  40. Hayes Inc. Hayes Technology Brief. Percutaneous Extracorporeal Transseptal Ventricular Support Using the TandemHeart® PTVA® System (CardiacAssist Inc.) for Cardiogenic Shock and High-Risk Cardiac Interventions. Lansdale, PA. Hayes Inc. 03/07/07. Updated 03/18/08.
  41. HAYES Inc. Medical Technology Directory: Total Artificial Heart, temporary or Permanent Biventricular Support Device Lansdale, PA. Hayes Inc. 07/18/05, updated 07/11/07.
  42. HAYES Inc. Medical Technology Directory: Ventricular Assist Devices. Lansdale, PA. Hayes Inc. 05/HAYES Medical Technology Directory: ”Ventricular Assist Devices” 05/06/05, updated 05/11/06.
  43. Hernandez, Arian F., Shea, Alisa M., Milano, Carmelo A.; et al. Long-term Outcomes and Costs of Ventricular Assist Devices Among Medicare Beneficiaries. JAMA. 2008; 300(20):2398-2406.
  44. Institute for Clinical Systems Improvement; Technology Assessment abstract: “Left Ventricular Assist Devices as Permanent Implants” (05/02).
  45. InterQual® 2012.2. Care Planning: Procedures Adult. Left Ventricular Assist Device (LVAD) Insertion.
  46. La Torre MW, Centofanti P, Attisani M, Patanè F, Rinaldi, M. Posterior Ventricular Septal Defect in Presence of Cardiogenic Shock Early Implantation of the Impella Recover LP 5.0 as a Bridge to Surgery. © 2011 by the Texas Heart ® Institute, Houston. Volume 38, Number 1, 2011.
  47. Maini B et al. Real-World Use of the Impella 2.5 Circulatory Support System in Complex High-Risk Percutaneous Coronary Intervention: The USpella Registry. Catheterization and Cardiovascular Interventions 80:717–725 (2012).
  48. Matsumiya G. Right Ventricular Failure – A Continuing Problem in the New Era of Left Ventricular Assist Device Therapy. Circulation Journal Vol.76, December 2012.
  49. National Heart Lung and Blood Institute Website. Diseases and conditions index: what is a total artificial heart? Available at: http://www.nhlbi.nih.gov. (Accessed 08/18/11).
  50. National Heart Lung and Blood Institute Website. Diseases and conditions index: what is a ventricular assist device? Available at: http://www.nhlbi.nih.gov. (Accessed 8/18/11).
  51. National Institute for Health and Clinical Excellence. Interventional Procedure Guidance 177: Short-term circulatory support with left ventricular assist devices as a bridge to cardiac transplantation or recovery. June 2006.
  52. Roger VL et al. Executive Summary: Heart Disease and Stroke Statistics--2012 Update : A Report From the American Heart Association. Circulation. 2012;125:188-197.
  53. Rose EA MD, et al. Long-term Use of a Left Ventricular Assist Device for End-Stage Heart Failure”. N Eng J Med 2001; 345(20): 1435 – 1443.
  54. Schubert SA, Soleimani B, Pae WE. Case Report: Hemolysis and Pulmonary Insufficiency following Right Ventricular Assist Device Implantation. Case Reports in Transplantation Volume 2012, Article ID 376384.
  55. Sjauw KD, Engström AE, Vis MM, Boom W, Baan Jr. J, de Winter RJ, Tijssen JGP, Piek JJ, Henriques JPS. Efficacy and timing of intra-aortic counterpulsation in patients with ST-elevation myocardial infarction complicated by cardiogenic shock. Neth Heart J (2012) 20:402–409.
  56. Slaughter, Mark S., MD, Sobieski, Michael A., CCP, Gallagher, Collen, RN, Dia, Muhyaldeen, MD, Silver, Marc A., MD. Low Incidence of Neurologic Events during Long-Term Support with the HeartMate® XVE Left Ventricular Assist Device. Tex Heart Inst J. 2008; 35(3): 245–249.
  57. St. Anthony’s ICD-9-CM Code Book (current edition).
  58. U.S. Food and Drug Administration Approval letter: AbioCor Implantable Replacement Heart. 09/05/06. Accessed 05/31/07.
  59. U.S. Food and Drug Administration News Release: “FDA Approves Heart Assist Pump for Permanent Use” (11/06/02).
  60. U.S. Food and Drug Administration Listing of Humanitarian Device Exemptions (last updated 03/21/13). Accessed at http://www.fda.gov/ on 05/01/13.
  61. U.S. Food and Drug Administration HDE Submission H040006: AbioCor® Implantable Replacement Heart Instructions for Use. Accessed at http://www.fda.gov/ on 05/01/13.
  62. U.S. Food and Drug Administration (FDA). Approval order: CentriMag® Right Ventricular Assist System (RVAS). Accessed at: http://www.fda.gov on 05/01/13.
  63. U.S. Food and Drug Administration Impella 2.5 Plus 501k Summary K112892, September 6, 2012. Accessed at http://www.fda.gov on 05/01/13.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 05/23/13.

GUIDELINE UPDATE INFORMATION:

01/01/01

Medical Coverage Guideline developed.

01/01/02

Annual HCPCS coding update.

09/15/03

Reviewed; revised to delete investigational statement regarding VADs used for destination therapy and add coverage criteria for this indication; added new HCPCS codes for VADs; added clarification for VADs vs. artificial heart devices.

08/15/04

Scheduled review; revised title to include total artificial hearts; added procedure codes for artificial hearts.

05/15/05

Revision to add clarification regarding artificial heart or mechanical devices.

08/15/05

Scheduled review; no change in coverage statement.

08/15/06

Scheduled review (consensus review); no change in coverage statement.

07/15/07

Scheduled review; revised Description section; reformatted guideline; updated references.

07/15/08

Scheduled review; no change to position statement. Add CMS language for clinical trials. Update references. Update Internet links.

01/01/09

Annual HCPCS coding update: update descriptor 0048T; delete 0049T.

07/15/09

Scheduled review; no change in position statement. Update references.

01/01/10

Annual HCPCS coding update: add CPT codes 93750, 33981, 33982, & 33983 and HCPCS code Q0506; remove code range Q0480 – Q0505 and add codes with full descriptors for all replacement parts and accessories.

10/15/10

Revision; related ICD-10 codes added.

01/01/11

Annual HCPCS coding update. Added codes Q0478, Q0479. Revised descriptor for code Q0499.

10/15/11

Unscheduled review. Revised description section, position statement, CPT coding, ICD10 coding and definitions. Deleted Medicare Exception and updated references.

01/01/13

Annual CPT/HCPCS coding update. Added 33990, 33991, 33992 and 33993. Revised descriptor for 93750. Deleted 0048T and 0050T. Corrected descriptors for Q0478 and Q0479.

04/01/13

2nd quarter HCPCS coding update. Added Q0507, Q0508 and Q0509. Deleted Q0505.

06/15/13

Unscheduled review. Revised description section, position statement and program exceptions section. Updated references and reformatted guideline.

07/01/14

Deleted codes 92970 , 92971, 93750, Q0478, Q0479, Q0480, Q0481, Q0482, Q0483, Q0484, Q0485, Q0486, Q0487, Q0488, Q0489, Q0490, Q0491, Q0492, Q0493, Q0494, Q0495, Q0496, Q0497, Q0498, Q0499, Q0500, Q0501, Q0502, Q0503, Q0504, Q0506, Q0507, Q0508 and Q0509.

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is copyright 2013, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2013 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association.The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

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Date Printed: April 20, 2015: 09:21 PM