On August 12, 2020, the Centers for Medicare and Medicaid Services (CMS) released the PROPOSED NCD that addresses updating the coverage criteria for Artificial Hearts and related devices, including Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy (CAG-00453N).

CMS will be accepting comments on this Proposed NCD until September 11, 2020 11:59 PM ET. The 30-day public comment period provides an opportunity for all stakeholders (physicians, hospital administrators, professional societies, patients, and industry) to provide feedback to CMS regarding the proposed decision to ensure that Medicare patients continue to benefit from VADs as an appropriate treatment option for advanced stage heart failure. Comments can be conveniently submitted through the CMS website.

New Information

CMS proposed to update coverage for patients based on patient characteristics for VAD candidacy rather than on designations based on intent to treat (e.g., bridge-to-transplantation and destination therapy). The MOMENTUM 3 pivotal trial and the totality of the data demonstrated the strong therapeutic benefit of left ventricular assist devices (LVADs) regardless of device intent which aligns with the strong support generated from the initial comment period from many in the clinical community.

What did CMS Propose?*

CMS is proposing the following changes in the draft NCD for coverage consideration:

Item Current NCD 20.9.1 Proposed NCD
Covered devices and treatment FDA indicated for BTT and/or DT FDA approved for short-term (e.g., bridge-to-recovery and bridge-to-transplant) or long-term (e.g., destination therapy) mechanical circulatory support
Coverage criteria
  1. Post-cardiotomy
  2. Bridge-to-Transplant (BTT)
  3. Destination Therapy (DT)
Patients who meet the following criteria:
  • Have New York Heart Association (NYHA) Class IV heart failure;
  • 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 also 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
Listing requirement
  • BTT: Patient must be listed for heart transplant
  • The implanting site, if different than the Medicare-approved transplant center, must receive written permission from the transplant center prior to implantation of the VAD.
  • Listing requirement removed
  • Removing requirement for written permission if implant site is different from the transplant center

*The information included on this page summarizes the current NCD and the proposed NCD, but for a complete listing of the requirements of the current NCD and proposed NCD, please review the CMS website, located here.

Along with these proposed changes, several items from the current NCD remained the same:

Item Current and Proposed NCD
Facility (multi-disciplinary team)
  • Cardiothoracic surgeon with at least 10 implants over the past 36 months
  • Cardiologist
  • A VAD program coordinator
  • A social worker
  • A palliative care specialist
Surgeon volume requirements At least 10 implants over the course of 36 months
Other Medicare contractors provide coverage deliberation for VADs for the following:
  • right ventricular support
  • biventricular support
  • use in beneficiaries < age 18
  • use for complex congenital heart disease
  • and use with acute HF without a history of chronic HF

NCD does not address coverage in these situations.

In addition, CMS is proposing to eliminate Total Artificial Hearts from the NCD by ending coverage with evidence development and allowing Medicare administrative contractors to make coverage determinations for total artificial hearts at the local level.

Guide to Submitting Comments

CMS will be accepting public comments until September 11, 2020 11:59PM ET. Comments are submitted through the CMS website.

  • Key considerations to address:
    • Proposed updates to coverage criteria for removing intent-to-treat designations
    • Proposed updates to patient coverage criteria
  • Review the clinical experience and impact of HeartMate 3™ LVAS within your practice and/or at your institution.
  • Provide your support on appropriate coverage guidelines for Medicare so that beneficiaries may access this life-saving technology without the limitations of the intent-to-treat designations.

Indications, Safety & Warnings

Rx Only

Brief Summary: Prior to using these devices, please review the Instructions For Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

HeartMate 3™ LVAS Indications: The HeartMate 3 Left Ventricular Assist System is indicated for providing short- and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in patients with advanced refractory left ventricular heart failure.

HeartMate II™ LVAS Indications: The HeartMate II Left Ventricular Assist System is indicated for use as a “bridge to transplantation” for cardiac transplant candidates who are at risk of imminent death from non-reversible left ventricle failure. It is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure, who have received optimal medical therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation. The HeartMate II Left Ventricular Assist System is intended for use both inside and outside of the hospital, or for transportation of Left Ventricular Assist Device patients via ground ambulance, airplane, or helicopter.

HeartMate 3™ and HeartMate II™ LVAS Contraindications: The HeartMate 3 and HeartMate II Left Ventricular Assist Systems are contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.

HeartMate 3™ and HeartMate II™ LVAS Adverse Events: Adverse events that may be associated with the use of the HeartMate 3 or HeartMate II Left Ventricular Assist System are listed below: death, bleeding, cardiac arrhythmia, localized infection, right heart failure, respiratory failure, device malfunctions, driveline infection, renal dysfunction, sepsis, stroke, other neurological event (not stroke-related), hepatic dysfunction, psychiatric episode, venous thromboembolism, hypertension, arterial non-central nervous system (CNS), thromboembolism, pericardial fluid collection, pump pocket or pseudo pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) and possible pump thrombosis.

MAT-2007200 v1.0



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