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

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

The FDA approved becaplermin, the first biotechnology product to treat deep diabetic foot and leg ulcers, in December of 1997. This product is a recombinant human platelet-derived growth factor administered topically as an adjunct to other ulcer care treatments, such as sharp debridement, pressure relief and infection control. Becaplermin is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond, and have an adequate blood supply.

After the Centers for Medicare and Medicaid Services (CMS) released a national non-coverage determination on Autologous Blood-Derived Products for Chronic Non-Healing Wounds in December of 2003, an error was printed in the NCD manual.  The statement “Coverage for treatments utilizing becaplermin, a non-autologous growth factor for chronic non-healing subcutaneous non-healing wounds, will remain at local carrier discretion” is not accurate.  The correct statement should have read “Coverage for treatments utilizing becaplermin, a non-autologous growth factor for chronic non-healing subcutaneous wounds, will remain nationally non-covered.”

While CMS makes every effort to provide accurate and complete information, the erroneous coverage statement printed in the NCD manual regarding non-autologous blood-derived products was not intended to be part of the Decision Memorandum posted on December 15, 2003.

CMS has not made payments for treatments utilizing non-autologous platelet-derived wound healing formulas (e.g. becaplermin) for the years 2002-2004 and the first quarter of 2005.

Therefore, CMS is opening 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.”

Requestor Name(s)Internal Request
Formal Request Accepted and Review Initiated09/29/2005
Expected NCA Completion Date05/14/2006
Public Comment Period09/29/2005 - 10/29/2005
Proposed Decision Memo Released02/13/2006
Proposed Decision Memo Public Comment Period: 02/13/2006 - 03/15/2006 
Decision Memo Released04/27/2006
Comments for this NCA:View Public Comments
Lead Analyst(s)
  • Beverly A. Lofton, MHA
  • Niccole Corbin, DPM, MHA
Lead Medical Officer(s)
  • Lori Paserchia, MD

September 29, 2005

CMS opens this national coverage determination (NCD) to consider how to correct the coverage language in section 270.3 of the NCD manual, entitled “Blood-Derived Products for Chronic Non-Healing Wounds.” CMS is requesting public comment on these changes.

After considering the public comments, we will release a proposed decision memorandum. Instructions for submitting public comments can be found at https://www.cms.hhs.gov/coverage/8h.asp

February 13, 2006

CMS is requesting public comments on this proposed decision memorandum pursuant to section 731 of the Medicare Modernization Act. CMS encourages public comment on this proposed decision through our website: http://cms.hhs.gov/center/coverage.asp.

April 27, 2006

CMS posts final decision.
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