National Coverage Analysis (NCA) Tracking Sheet

Nesiritide for Treatment of Heart Failure Patients

CAG-00289N

Issue

Nesiritide is FDA approved for the short-term intravenous treatment of patients with acutely decompensated congestive heart failure (CHF) who have dyspnea (shortness of breath) at rest or with minimal activity.  Utilization data of this new therapy reveal a rapid and steady increase during the past two years.   The major contributing factor to this increased utilization is related to the “off-label” use of intravenous Nesiritide in chronic CHF and maintenance therapy, especially in the outpatient setting.

Recent studies have assessed the effectiveness of nesiritide use for treatment of chronic heart failure in outpatient settings and a recent independent advisory panel of cardiac experts sponsored by Scios, manufacturer of Natrecor® (nesiritide), recommends that nesiritide be restricted to the treatment of acute decompensated heart failure in the inpatient hospital setting.  In addition, recent published articles in the peer-reviewed medical literature have highlighted concerns about renal failure and mortality in persons using Nesiritide.

Benefit Category

No Benefit Category

Requestor Information

Requestor Name Requestor Letter
Charles Haley View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
06/29/2005
Expected NCA Completion Date
03/02/2006
Public Comment Period
06/29/2005 - 07/29/2005
Proposed Decision Memo Due Date
Proposed Decision Memo Released
12/02/2005
Proposed Decision Memo Public Comment Period
12/02/2005 - 01/02/2006
Decision Memo Released
03/02/2006
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Michael Lyman, RN, MPH
Lead Medical Officers
James Rollins, MD, MSHA, PhD

Medicare Benefit Category Determination Date

Actions Taken

June 29, 2005

CMS is opening an NCD to evaluate the use of nesiritide in the Medicare population. CMS begins national coverage determination review in response to an external request.   We are interested in all public comments on its use. A 30-day public comment period opens. Instructions on submitting comments can be found at https://www.cms.hhs.gov/coverage/8h.asp

July 22, 2005

CMS posts a correction to the Issue section of the tracking sheet more correctly identifying the expert panel arranged by Scios.

July 29, 2005

End of 30 Day Public Comment Period. 136 public comments received.

August 16, 2005

As a clarification to the public, CMS is only focusing on the off-label use of nesiritide in this NCD.

December 2, 2005

CMS is posting its Proposed Decision Memorandum  for a 30 day public comment period.

Instructions for submitting public comments are available at http://www.cms.hhs.gov/coverage/8h.asp.

December 8, 2005

CMS revises the Expected NCA Completion Date on the Tracking Sheet to 3/2/2006 from 3/29/2006. This change allows 60 days from close of the 30 Day Public Comment Period for CMS to complete the NCA.

January 2, 2006

The 30 day public comment period to respond to the Proposed Decision Memorandum closes. A total of 40 timely public comments were received.

March 2, 2006

CMS is posting its Final Decision Memorandum. The final decision memorandum is posted and can be reviewed here.