National Coverage Analysis (NCA) Tracking Sheet

Erythropoiesis Stimulating Agents (ESAs) for non-renal disease indications

CAG-00383N

Issue

The United States Food and Drug Administration (FDA) recently issued alerts and warnings for ESAs administered for a number of clinical conditions, including cancer and renal disease. Recently published studies report a higher risk of serious and life-threatening events associated with the use of ESAs in various clinical applications.

ESAs stimulate the bone marrow to make more red blood cells and are FDA approved for use in reducing the need for blood transfusion in patients with specific clinical indications.

CMS is internally opening a National Coverage Analysis to evaluate the uses of ESAs in non-renal disease applications.

Benefit Category

Drugs and Biologicals

Requestor Information

Requestor Name Requestor Letter
CMS Generated N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
03/14/2007
Expected NCA Completion Date
08/12/2007
Public Comment Period
03/14/2007 - 04/13/2007
Proposed Decision Memo Due Date
Proposed Decision Memo Released
05/14/2007
Proposed Decision Memo Public Comment Period
05/14/2007 - 06/13/2007
Decision Memo Released
07/30/2007
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Maria Ciccanti, RN
Kimberly Long
Kimberly.long@cms.hhs.gov
410-786-5702
Lead Medical Officers
Elizabeth Koller, MD, FACE
Shamiram Feinglass, MD, MPH

Medicare Benefit Category Determination Date

Actions Taken

March 14, 2007

CMS initiates an NCA on administration of ESAs for non-renal disease applications. 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 technology under.

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

Public comments are currently not viewable on the CMS website after they have been submitted. We are working to address this.

May 14, 2007

CMS posts the proposed decision memorandum (PDM) and invites public comment. The title of the PDM is revised to reflect the scope of the analysis and proposed decision. The PDM 30 day public comment period begins.

July 12, 2007

Posted comments [PDF, 33MB] received.

View comments received through the website.

July 30, 2007

CMS posts the final decision memo.