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Coverage criteria policies

Ventricular Assist Devices (VADs) & Total Artificial Hearts – Minnesota Health Care Programs

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Prior authorization is required for insertion of an implantable Ventricular Assist Device (VAD) except in the event that the device is used under emergency circumstances in a critically ill member who is in an in-patient setting. However, services with specific coverage criteria may be reviewed concurrently or retrospectively to determine whether coverage criteria are being met. Retrospective denial may result if criteria are not met. Emergency use is defined as necessary to save the life or protect the immediate well-being of a given patient.

Prior authorization is not applicable for placement of a Total Artificial Heart (TAH) as this is not a covered benefit under Minnesota Health Care Programs (MHCP).

Coverage

Insertion of an implantable Ventricular Assist Device (VAD) is generally covered subject to the indications listed below and per your plan documents when the procedure is performed at a HealthPartners Designated Transplant Center. Please see the Related Content section for the Designated Transplant Centers document

Indications that are covered- Implantable Ventricular Assist Device-Adult

  1. An implantable VAD is covered as a Bridge to Recovery in patients with a potentially reversible condition when the following criteria are met:
    1. The requested device has received approval from the Food and Drug Administration (FDA) and is being used in accordance with device-specific, FDA-approved indications.
    2. The patient is in acute cardiogenic shock from which recovery is expected or the patient is unable to be weaned from cardiopulmonary bypass following heart surgery.
  2. An implantable VAD is covered as a Bridge to Transplant when the following criteria are met:
    1. The requested device has received approval from the Food and Drug Administration (FDA) and is being used in accordance with device-specific, FDA-approved indications.
    2. The patient is undergoing evaluation to determine candidacy for heart transplantation; or
    3. The patient is currently listed as a heart transplantation candidate at a HealthPartners Designated Transplant Center and is not expected to survive until a donor heart can be obtained.
  3. An implantable VAD is covered as Destination Therapy for a patient who is not a candidate for heart transplant when the following criteria are met:
    1. The requested device has received approval from the Food and Drug Administration (FDA) and is being used in accordance with device-specific, FDA-approved indications.
    2. There is documentation of New York Heart Association (NYHA) Class IV end-stage left ventricular heart failure for at least 90 days duration and the patient has a life expectancy of less than 2 years; and
      1. The Class IV heart failure symptoms have failed to respond to optimal medical management, (including beta-blockers, and ACE inhibitors if tolerated) for at least 45 of the last 60 days; or
      2. The patient has been intra-aortic balloon pump dependent for 7 days, or IV inotrope dependent for 14 days; and
      3. The left ventricular ejection fraction (LVEF) is less than 25%; and
      4. There are demonstrated functional limitations, with a peak oxygen consumption of less than or equal to 14 milliliters per kilogram of body weight per minute.

Indications that are not covered - Ventricular Assist Device-Adult

  1. Percutaneous ventricular assist devices (pVAD) are considered investigational for all indications.

Indications that are covered - Implantable Ventricular Assist Device-Pediatric

An implantable VAD is covered as a Bridge to Transplant in children when all of the following criteria are met:

  1. The requested device has received approval from the Food and Drug Administration (FDA) and is being used in accordance with the device-specific, FDA-approved indications.
  2. There is documentation of NYHA Class IV, end-stage heart failure/end-stage left ventricular failure; and
  3. The patient is currently undergoing evaluation to determine candidacy for heart transplantation or is listed as a cardiac transplant candidate at a HealthPartners Designated Transplant Center.

Indications that are not covered - Implantable Ventricular Assist Device-Pediatric

Pediatric VADs are considered not medically necessary and are not covered for use in children when all the criteria specified above are not met, or when any of the following contraindications are present:

  1. Right ventricular failure; or
  2. Blood clotting (primary coagulopathy) or platelet disorder such as hemophilia or Von Willebrand’s disease; or
  3. Known allergy or sensitivity to the blood thinner heparin or an appropriate alternative anti-coagulant; or
  4. Major neurological deficit; or
  5. Systemic infection present

Indications that are not covered – Total Artificial Heart

Placement of a total artificial heart is not a covered benefit for any indication.

Definitions

Ventricle- is one of a pair of muscular chambers of the heart that pumps blood throughout the body.

Ventricular Assist Device (VAD) describes any of a variety of mechanical pumps that are used to replace the function of either the right, left, or both ventricles to assist a damaged or weakened heart to pump blood.

Percutaneous ventricular assist devices (pVAD) were introduced as an alternative to the intra-aortic balloon pump (IABP) in individuals with cardiogenic shock following acute myocardial infarction (heart attack). These are external blood pumps which are held in place, usually on the thigh, by a holster, where it resides outside the body until discontinued. They are intended for short term use in members who require acute circulatory support.

Total Artificial Heart (TAH) is an implantable support device that serves as a total replacement for both ventricles of a failing heart. The ventricles and valves are surgically removed and the device is sewn to the remaining atria (top half of the heart). The TAH replaces the function of the two ventricles and four valves of the heart to pump blood to the lungs and systemic circulatory system.

Adult is defined as age 18 years old and above.

Pediatric is defined as below the age of 18 years old.

Bridge to Recovery refers to short term (usually one day to two weeks) use of mechanical circulatory support in a patient with a potentially reversible cardiac condition.

Bridge to Transplant refers to the use of a mechanical support device while the patient is awaiting a heart transplant.

Destination Therapy refers to permanent support for a member with irreversible heart failure who is not a candidate for heart transplantation.

Heart Failure is a chronic, progressive disease in which the heart muscle weakens and can no longer pump enough blood to sustain the body systems. Vital organs like the kidneys, liver and brain are starved of the oxygen and nutrients they need in order to function properly. Heart failure often develops after the heart has been damaged or weakened by other conditions, including coronary artery disease, heart attack, high blood pressure and cardiomyopathy.

New York Heart Association (NYHA) Classification: The most commonly used classification system of heart failure. It places the individual in one of four categories based on degree of limitation during physical activity, using the limitations/symptoms related to degrees of breathing difficulty, shortness of breath, and/or angina pain.

Class I (Mild) - No limitation of physical activity.

Class II (Mild) - Slight limitation of physical activity

Class III (Moderate) - Marked limitation of physical activity; comfortable at rest, but less than ordinary physical activity results in symptoms of heart failure such as fatigue, rapid/irregular heartbeat or shortness of breath.

Class IV (Severe) - Inability to carry on any physical activity without discomfort. Symptoms of heart failure are present at rest.

End stage heart failure refers to the most severe stage of heart failure in which both sides of the heart are failing to pump enough blood to sustain the body

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

Ventricular Assist Device

Codes

Description

33975

Insertion of ventricular assist device; extracorporeal, single ventricle

33976

Insertion of ventricular assist device; extracorporeal, biventricular

33977

Removal of ventricular assist device; extracorporeal, single ventricle

33978

Removal of ventricular assist device; extracorporeal, biventricular

33979

Insertion of ventricular assist device, implantable intracorporeal, single ventricle

33980

Removal of ventricular assist device, implantable intracorporeal, single ventricle

33981

Replacement of extracorporeal ventricular assist device, single or biventricular, pump(s), single or each pump

33982

Replacement of ventricular assist device pump(s); implantable intracorporeal, single ventricle, without cardiopulmonary bypass

33983

Replacement of ventricular assist device pump(s); implantable intracorporeal, single ventricle, with cardiopulmonary bypass

33990

Insertion of ventricular assist device, percutaneous including radiological supervision and interpretation; arterial access only

33991

Insertion of ventricular assist device, percutaneous including radiological supervision and interpretation; both arterial and venous access, with transseptal puncture

33992

Removal of percutaneous ventricular assist device at separate and distinct session from insertion

33993

Repositioning of percutaneous ventricular assist device with imaging guidance at separate and distinct session from insertion.

93750

Interrogation of ventricular assist device (VAD), in person, with physician analysis of device parameters (e.g., drivelines, alarms, power surges), review of device function (e.g., flow and volume status, septum status, recovery), with programming, if performed, and report

Total Artificial Heart

Codes

Description

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

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. Portions of this policy were taken from the MHCP Provider Manual-Member Evidence of Coverage http://www.dhs.state.mn.us/main/idcplg?IdcService=GET_DYNAMIC_CONVERSION&RevisionSelectionMethod=LatestReleased&dDocName=DHS16_179701#cs in addition to the resources cited below (2-17).
  2. Ait, Ichou, Larivee, N., Eisenberg, M.Suissa, K. and Filion, K. (2017) The effectiveness and safety of the Impella ventricular assist device for high-risk percutaneous coronary interventions: A systematic review. Catheter Cardiovascular Intervention. Epub ahead of print, Sept 20, 2017. .
  3. Aroesty, J. Jeevanadam, V. and Eisen, H. Short-term mechanical circulatory assist devices. In: UpToDate, Cutlip, D. (Ed), UpToDate, Waltham, MA. (Accessed on Oct 18, 2017).
  4. Birks, EJ. Intermediate and long-term mechanical circulatory support. In: UpToDate, Mancini, D. and Hunt, S. (Ed), UpToDate, Waltham, MA. (Accessed on Oct 18, 2017).
  5. ECRI Institute. (Apr. 2013). Emerging Technology Evidence Report. Pediatric Ventricular Assist Device (Excor) as Bridge to Transplantation. Plymouth Meeting, PA: ECRI Institute.
  6. ECRI Institute. (Mar. 2016). Custom Product Brief. Impella CP (Abiomed, Inc.) for Treating Left Ventricular Heart Failure. Plymouth Meeting, PA: ECRI Institute.
  7. Gersh, B., Maron, B., Bonow, R., Dearani, J., Fifer, M., Link, M. …and Yancy, C. (2011). AACF/AHA Guideline for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy- A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Journal of the American College of Cardiology, 58(25); e212-260.
  8. Hayes Inc. Search and Summary. Ventricular Assist Devices (VADs) in Children and Adolescents with Chronic, End-Stage Heart Failure. Lansdale, PA: Hayes, Inc. Sept 2015.
  9. Hayes Inc. Hayes Medical Technology Directory Report. Left Ventricular Assist Devices (LVADS) in Adult Patients with Chronic, End-Stage Heart Failure. Lansdale, PA: Hayes, Inc. Aug, 2010, Reviewed Aug, 2014/Archived Sept, 2015.
  10. Hayes Inc. Hayes Product Brief. Impella 5.0 (Abiomed, Inc) for Emergent Hemodynamic Support in Patients with Cardiogenic Shock. Lansdale, PA: Hayes, Inc. Sept, 2015, Reviewed 7/2017.
  11. Hayes, Inc. Hayes Health Technology Brief. Impella 2.5 System (Abiomed Inc.) for Cardiac Support in Patients Undergoing High-Risk Percutaneous Coronary Intervention (PCI). Lansdale, PA: Hayes, Inc.; Oct, 2017.
  12. Hayes, Inc. Hayes Prognosis Snapshot. Impella RP for Right Heart Failure. Lansdale, PA: Hayes, Inc.; Oct, 2017.
  13. Hayes, Inc. Hayes Clinical Research Response. TandemHeart (CardioAssist, Inc) for Bridge to Recovery. Lansdale, PA: Hayes, Inc.; Sept, 2017
  14. Institute for Clinical Systems Improvement (ICSI). Heart Failure in Adults Guideline- Executive Summary. July, 2013. Accessed, Aug, 2016.
  15. Lindenfeld J., Albert NM, Boehmer JP, Collins SP, Ezekowitz JA, Givertz MM, Klaphotz M,Moser DK, Rogers JG, Starling RC, Stevenson WG, Tang WHW, Teerlink JR, Wals MN. Executive Summary: Heart Failure Society of America 2010 Comprehensive Heart Failure Practice Guideline. Journal of Cardiac Failure. 2010; 16(6):475-539.
  16. Peura, J., Colvin-Adams, M., Francis, G., Grady, K. Hoffman, T., Jessup, M. …and Toole, M. (2012). Recommendations for the Use of Mechanical Circulatory Support: Device Strategies and Patient Selection- A Scientific Statement From the American Heart Association. Circulation- American Heart Association Journal. 126; 2648-2667.
  17. Rendon, R., Acharya, D., Pamboukian, S. et al. Duration of Heart Failure is an Important Predictor of Outcomes After Mechanical Circulatory Support. Circulation: Heart Failure. 2015;8:953-959

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Policy activity

  • 11/15/2017 - Date of origin
  • 11/15/2017 - Effective date

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