National Coverage Analysis (NCA) Tracking Sheet

Autologous Blood-Derived Products for Chronic Non-Healing Wounds

CAG-00190N

Issue

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.

Benefit Category

Incident to a physician's professional Service

Requestor Information

Requestor Name Requestor Letter
Internally Generated N/A
N/A

Important Dates

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
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
12/15/2003

Contacts

Lead Analysts
Mary Stojak
Niccole Corbin
Lead Medical Officers
Lori Paserchia, M.D.

Medicare Benefit Category Determination Date

Actions Taken

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