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.”
