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National Coverage Analysis (NCA) Tracking Sheet for Autologous Blood-Derived Products for Chronic Non-Healing Wounds (CAG-00190N)

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In 1994, CMS published an NCD called Platelet-Derived Wound Healing Formula (CIM 45-26) based on the Agency’s evaluation of Procuren™.   The determination was for national non-coverage.

Subsequently, other blood-derived products have been used to treat wounds and confusion has arisen both among CMS contractors and the medical community as to their inclusion under CIM 45-26.   CMS has determined that opening an NCD will facilitate updating this topic with more recent evidence and a more complete listing of affected products.
Incident to a physician's professional Service
Requestor Name(s):  Internally Generated
Formal Request Accepted and Review Initiated:  05/08/2003
Expected NCA Completion Date:  08/11/2003
Public Comment Period:  06/09/2003 - 07/09/2003
Decision Memo Released:  12/15/2003
Lead Analyst(s): 
  • Mary Stojak
  • Niccole Corbin
Lead Medical Officer(s): 
  • Lori Paserchia, M.D.
May 8, 2003

Opened formal NCD request and posted tracking sheet on the Internet.   CMS is investigating the processes that utilize blood-derived products for the healing of chronic wounds.  We are requesting comments on similar products available.

Additional Lead Analyst: Betty Shaw, 410-786-4165
August 11, 2003 Internal Technology Assessment completed.
December 15, 2003 Decision memorandum posted to website
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