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National Coverage Analysis (NCA) Tracking Sheet for Autologous Blood Derived Products for Chronic Non-Healing Wounds (CAG-00190R2)

In 1992, CMS issued a national non-coverage determination for autologous, platelet-derived wound healing formulas intended to treat patients with chronic, non-healing wounds.

In December 2003, CMS issued a national non-coverage determination for use of autologous platelet-rich plasma (PRP) for the treatment of chronic non-healing cutaneous wounds except when used in accordance with the clinical trial policy defined in section 30-1 of the Coverage Issues Manual.

In April 2005, CMS issued a national coverage determination (NCD) to correct the error printed in the 270.3 section of the NCD manual, entitled “Blood-Derived Products for Chronic Non-Healing Wounds.”

On June 20, 2007, Cytomedix submitted a formal request to CMS to reconsider coverage of autologous blood-derived products when used for the treatment of chronic non-healing wounds.

Autologous PRP is a prevalent blood product used for treating chronic non-healing wounds, open cutaneous wounds, soft tissue, and bone. 

Cytomedix has submitted new evidence and requests CMS’ re-evaluation of the coverage of PRP gel for the following open-cutaneous wounds, including chronic wounds:

  1. Wounds caused by an acute surgical incision or dehiscence.
  2. Full-thickness chronic wounds that have failed an adequate course of standard wound therapy.
Incident to a physician's professional Service
Requestor Name(s)Kshitij Mohan, PH.D. (Cytomedix)
Requestor Letter(s)View Letter
Formal Request Accepted and Review Initiated06/25/2007
Expected NCA Completion Date03/19/2008
Public Comment Period06/25/2007 - 07/25/2007
Proposed Decision Memo Released12/20/2007
Proposed Decision Memo Public Comment Period: 12/20/2007 - 01/19/2008 
Decision Memo Released03/19/2008
Comments for this NCA:View Public Comments
Lead Analyst(s)
  • Beverly A. Lofton, MHA
Lead Medical Officer(s)
  • Lori Paserchia, MD

June 25, 2007

CMS opens this national coverage determination (NCD) to reconsider coverage of PRP gel for treatment of chronic non- healing wounds based on new evidence regarding this indication.

CMS is requesting public comments on this issue. After considering the public comments, CMS will release a proposed decision memorandum.

The initial public comment period begins.

December 5, 2007

Posted comments [PDF, 1MB] received.

View comments received through the website.

December 20, 2007

The proposed decision memo is issued and posted.

The final public comment period begins.

CMS is particularly interested in comments that address CMS' proposed decision.

January 29, 2008

Posted comments [PDF, 1MB] received.

View comments received through the website.

March 19, 2008

Final Decision Memorandum posted.
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