CARDIOVASCULAR
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CMS Released the Final National Coverage Determination (NCD) for VADS Based on the Latest Reconsideration Request to Remove Intent-to-Treat Designations

On December 1st, 2020, the Centers for Medicare and Medicaid Services (CMS) finalized and released their most recent update to the coverage criteria for Ventricular Assist Devices (VADs).

CMS finalized the NCD for Ventricular Assist Devices after considering comments from providers, professional societies, and other stakeholders from the public comment period generated by the Proposed NCD.

Key Information

CMS finalized the coverage criteria for patients based on 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. The Final NCD for VADs is effective for dates of service on and after December 1st, 2020.

What did CMS Update?*

Item Previous NCD 20.9.1 Final NCD Effective on December 1st, 2020
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; and
  • Have a left ventricular ejection fraction (LVEF) ≤ 25%; and
  • 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
Facility
(multi-disciplinary team)
  • Cardiothoracic surgeon implanting at least 10 durable, intracorporeal LVADs over the past 36 months with activity in the last year
  • Cardiologist - with clinical competencies in heart transplants required
  • A VAD program coordinator
  • A social worker
  • A palliative care specialist
  • Cardiothoracic surgeon implanting at least 10 durable, intracorporeal LVADs over the past 36 months with activity in the last year
  • Cardiologist - with clinical competencies in VADs required
  • A VAD program coordinator
  • A social worker
  • A palliative care specialist

Along with these finalized changes, several items from the previous NCD remained the same*:

Item Previous and Updated NCD Effective on December 1st, 2020
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 also finalized the decision to remove Total Artificial Hearts from the NCD and remove the coverage with evidence requirement by allowing coverage for TAH to be made by the local Medicare Administrative Contractors (MACs).

As a result, effective on December 1, 2020, NCD 20.9.1 is reserved exclusively for VADs.

*The information included on this page summarizes the previous NCD and the updated NCD effective on December 1st, 2020. For a complete listing of the requirements of the Final NCD, please review the CMS website, located here.

Resources

If you have reimbursement questions, please email us at VADReimbursement@abbott.com or contact us through the reimbursement hotline. Hotline support is available from 8 a.m. to 5 p.m. Central Time, Monday through Friday at (855) 569-6430. Customer reimbursement support is subject to the disclaimers set forth in this Guide.

Additionally, you can visit our reimbursement website to find such resources as Mechanical Circulatory Support (MCS) coding guides, general MCS FAQs, and reimbursement webinars.

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.

 

DISCLAIMER: This document and the information contained herein is for general information purposes only and is not intended and does not constitute legal, reimbursement, coding, business or other advice. Furthermore, it is not intended to increase or maximize payment by any payer. Nothing in this document should be construed as a guarantee by Abbott regarding levels of reimbursement, payment or charge, or that reimbursement or other payment will be received. Similarly, nothing in this document should be viewed as instructions for selecting any particular code. The ultimate responsibility for coding and obtaining payment/reimbursement remains with the customer. This includes the responsibility for accuracy and veracity of all coding and claims submitted to third party payers. Also note that the information presented herein represents only one of many potential scenarios, based on the assumptions, variables and data presented. In addition, the customer should note that laws, regulations, coverage and coding policies are complex and updated frequently. Therefore, the customer should check with their local carriers or intermediaries often and should consult with legal counsel, a compliance officer or a financial, coding or reimbursement specialist for any coding, reimbursement or billing questions or related issues. This information is for reference purposes only. It is not provided or authorized for marketing use.

 

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