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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.
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
July 12, 2007
Posted comments [PDF, 33MB] received.
View comments received through the website.
July 30, 2007