| 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.
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| National Coverage Determination(s) |
| 110.21
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| Benefit Category |
| Drugs and Biologicals |
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| Requestor Name(s) |
|
CMS Generated |
| |
| Formal Request Accepted and Review Initiated |
| 3/14/2007 |
| |
| Expected NCA Completion Date |
| 8/12/2007 |
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| Proposed Decision Memo Due Date |
| 9/14/2007 |
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| Proposed Decision Memo Released |
| 5/14/2007 |
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| Decision Memo Released |
| 7/30/2007 |
| |
| Lead Analyst(s) |
Maria Ciccanti, RN
maria.ciccanti@cms.hhs.gov
1-410-786-3107
Kimberly Long
Kimberly.long@cms.hhs.gov
1-410-786-5702
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| |
| Lead Medical Officer(s) |
Elizabeth Koller, MD, FACE
Shamiram Feinglass, MD, MPH
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| Actions Taken |
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| March 14, 2007
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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/InfoExchange/02_publiccomments.asp#TopOfPage
Public comments are currently not viewable on the CMS website after they have been submitted. We are working to address this.
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| 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.
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| July 30, 2007 |
CMS posts the final decision memo. |
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