National Coverage Analysis (NCA) Tracking Sheet

Artificial Hearts and related devices, including Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy

CAG-00453N

Issue

An artificial heart is an implanted prosthetic device that replaces the heart. Ventricular assist devices (VADs) or left ventricular assist devices (LVADs) are mechanical blood pumps that are surgically attached to one or both intact ventricles of a damaged or weakened native heart to assist in pumping blood. A relatively small proportion of patients suffer from biventricular failure. The artificial heart is a biventricular replacement device. Use of an artificial heart requires removal of both ventricles and removal of the device is not possible. In contrast, the heart remains intact with VADs with the possibility for the native heart to recover and for removal of the device.

Section 20.9 of the Medicare National Coverage Determinations (NCD) Manual outlines the conditions of coverage for Artificial hearts and related devices, including VADs (see section 20.9.1). Currently, Medicare covers artificial hearts under coverage with evidence development (CED) when beneficiaries are enrolled in a clinical study that meets all of the criteria specified in the NCD. VADs are currently covered for postcardiotomy (after open-heart surgery); bridge-to-transplant (while patients await heart transplantation) and destination therapy (for patients not eligible for heart transplantation).

CMS received two complete, formal requests. The first requested that CMS reconsider CED for artificial hearts based on evidence generated since the NCD was updated in 2008. The second NCD request asked that CMS reconsider VADs specifically for coverage indications for bridge-to-transplant and destination therapy based on scientific evidence generated since the NCD was last reconsidered in 2013.

CMS is soliciting public comment relevant to the NCD request. We are interested in public comments that include scientific evidence related to this NCD review. For NCD 20.9.1 (i.e., VADs), the scope of this reconsideration is limited to the coverage requirements for bridge-to-transplant and destination therapy. We are specifically interested in public comments regarding the VAD facility requirements for bridge-to-transplant and destination therapy.

Benefit Category

Inpatient Hospital Services
Prosthetic Devices

Requestor Information

Requestor NameRequestor Letter
Abbott View Letter
Syncardia View Letter

Important Dates

Formal Request Accepted and Review Initiated
02/03/2020
Expected NCA Completion Date
11/10/2020
Public Comment Period
02/03/2020 - 03/04/2020
Proposed Decision Memo Released
08/12/2020
Proposed Decision Memo Public Comment Period
08/12/2020 - 09/11/2020
Decision Memo Released
12/01/2020
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Rachel Katonak
Rachel.Katonak@cms.hhs.gov
410-786-8564
Lead Medical Officers
Joseph Hutter, MD, MAD

Actions Taken

February 3, 2020

CMS initiates this national coverage analysis for Sections 20.9 and 20.9.1 of the NCD Manual. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the topic under review.

Instructions on submitting comments can be found at: http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html.

To submit a comment, please use the orange "Comment" button at the top of the page. Enter comments directly into the "Submit A Public Comment" webpage. We strongly urge that all public comments be submitted through this website. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.

August 12, 2020

December 1, 2020