National Coverage Analysis (NCA) Tracking Sheet

Implantable Cardioverter Defibrillators

CAG-00157R4

Issue

An implantable cardioverter defibrillator (ICD) is an electronic device designed to diagnose and treat life-threatening ventricular tachyarrhythmias. The device consists of a pulse generator and electrodes for sensing and defibrillating.

Section 20.4 of the Medicare National Coverage Determinations (NCD) Manual establishes conditions of coverage for implantable cardioverter defibrillators. In 1986 CMS first issued an NCD providing limited coverage of implantable defibrillators and the policy has been expanded over the years. CMS last reconsidered this NCD in 2005.

CMS is opening this national coverage analysis to reconsider coverage indications for implantable cardioverter defibrillators.

Benefit Category

Prosthetic Devices

Requestor Information

Requestor NameRequestor Letter
Internally generated N/A

Important Dates

Formal Request Accepted and Review Initiated
05/30/2017
Expected NCA Completion Date
02/20/2018
Public Comment Period
05/30/2017 - 06/29/2017
Proposed Decision Memo Released
11/20/2017
Proposed Decision Memo Public Comment Period
11/20/2017 - 12/20/2017
Decision Memo Released
02/15/2018
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
David Dolan, MBA, MA
david.dolan@cms.hhs.gov
410-786-3365
Daniel Canos, PhD.
Lead Medical Officers
Joseph Hutter, MD, MA

Actions Taken

May 30, 2017

CMS initiates this national coverage analysis for reconsideration of Section 20.4 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 comments that include clinical studies and other scientific evidence.

Instructions on submitting public comments can be found at https://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html. You can also submit a public comment by clicking on the highlighted word comment in the title bar at the top of this page. 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.

November 20, 2017

February 15, 2018