MM12290

=== Page 1 === mnn MATTERS® KNOWLEDGE • RESOURCES • TRAINING # National Coverage Determination (NCD) 20.9.1 ## Ventricular Assist Devices (VADs) MLN Matters Number: MM12290 Related CR Release Date: June 11, 2021 Effective Date: December 1, 2020 Related CR Transmittal Number: R10837CP and R10837NCD Implementation Date: July 27, 2021 ## Provider Types Affected This MLN Matters Article is for physicians and providers billing MACs for VAD services they provide to Medicare beneficiaries. ## Provider Action Needed - Chapter 1, Part 1, Section 20.9 of the Medicare NCD Manual - Chapter 32, Section 320 of the Medicare Claims Processing Manual The CR transmittals contain the revised chapters as attachments. Be sure your billing staffs are aware of these changes. ## Background In 1993, CMS first issued an NCD providing limited coverage of VADs and we have expanded the policy over the years. We last reconsidered this NCD in 2013. VADs or left ventricular assist devices (LVADs) are mechanical blood pumps that are surgically attached to 1 or both intact ventricles of a damaged or weakened native heart to assist in pumping blood. Medicare covers LVADs if the FDA approves them for short-term (for example, bridge-to-recovery and bridge-to-transplant) or long-term (for example, destination therapy) mechanical circulatory support for heart failure patients meeting the following criteria: - Have New York Heart Association (NYHA) Class IV heart failure; and - Have a left ventricular ejection fraction (LVEF) ≤ 25%; and CMS CENTERS FOR MEDICARE & MEDICAID SERVICES Medicare Learning Network === Page 2 === MLN Matters: MM12290 - Are inotrope dependent OR have a Cardiac Index (CI) < 2.2 L/min/m2 while not on inotropes and meet 1 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 - 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 An explicitly identified, cohesive, multidisciplinary team of medical professionals with appropriate qualifications, training, and experience must manage patients receiving a VAD. The team must make sure that patients and caregivers have the knowledge and support necessary to participate in informed decision making. The team members must be based at the facility and must include individuals with experience working with patients before and after placement of a VAD. The team must include, at a minimum: - At least 1 physician with cardiothoracic surgery privileges and individual experience implanting at least 10 durable, intracorporeal, LVADs over the course of the previous 36 months with activity in the last year - At least 1 cardiologist trained in advanced heart failure with clinical competence in medical-based and device-based management, including VADs, and clinical competence in the management of patients before and after placement of a VAD - A VAD program coordinator - A social worker - A palliative care specialist To learn how organizations apply for CMS approval to be designated as a credentialing organization for VAD facilities, visit the CMS VAD Therapy Facilities page. This page also includes: - A list of approved credentialing organizations - Approved standard versions - Credentialed facilities ## More Information For more information, contact your MAC. CMS CENTERS FOR MEDICARE & MEDICAID SERVICES Medicare Learning Network === Page 3 === MLN Matters: MM12290 # Document History | Date of Change | Description | | --- | --- | | June 14, 2021 | Initial article released. | Disclaimer: Paid for by the Department of Health & Human Services. This article was prepared as a service to the public and is not intended to grant rights or impose obligations. This article may contain references or links to statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of either the written law or regulations. We encourage readers to review the specific statutes, regulations and other interpretive materials for a full and accurate statement of their contents. CPT only copyright 2019 American Medical Association. All rights reserved. Copyright © 2013-2020, the American Hospital Association, Chicago, Illinois. Reproduced by CMS with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB-04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312-893-6816. Making copies or utilizing the content of the UB-04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB-04 Manual and/or codes and descriptions; and/or making any commercial use of UB-04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. To license the electronic data file of UB-04 Data Specifications, contact Tim Carlson at (312) 893-6816. You may also contact us at ub04@healthforum.com The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates. CMS CENTERS FOR MEDICARE & MEDICAID SERVICES Medicare Learning Network

CMS covers Ventricular Assist Devices (VADs) under certain criteria effective December 1, 2020. Medicare covers LVADs for patients with NYHA Class IV heart failure. Patients must have a left ventricular ejection fraction (LVEF) of 25% or less. Patients are inotrope dependent or have a Cardiac Index (CI) < 2.2 L/min/m2 while not on inotropes and meet one of the following: are on optimal medical management 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. Facilities must have a minimum of one physician with cardiothoracic surgery privileges and experience implanting at least 10 durable LVADs in the past 36 months. Facilities must include at least one cardiologist trained in advanced heart failure management, including VADs.

An explicitly identified, cohesive, multidisciplinary team must manage patients receiving a VAD. All team members must have appropriate qualifications, training, and experience related to VAD management.

Documentation of optimal medical management adherence. Clinical evidence supporting the need for mechanical circulatory support. Evidence of a VAD program coordinator's qualifications. Documentation of social worker and palliative care specialist involvement.