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:
- Wounds caused by an acute surgical incision or dehiscence.
- Full-thickness chronic wounds that have failed an adequate course of standard wound therapy.