BioCentury
ARTICLE | Clinical News

AutoloGel System regulatory update

March 11, 2013 7:00 AM UTC

Cytomedix said the Centers for Medicare & Medicaid Services (CMS) granted formal approval for Medicare reimbursement of autologous platelet-rich plasma (PRP) gel to treat chronic, non-healing diabetic, venous and/or pressure wounds under CMS's coverage with evidence development (CED) mechanism. The company said that CMS approved the clinical outcomes defined in 4 protocols developed and submitted by Cytomedix in response to the National Coverage Determination (NCD) memo issued by CMS last August. In August, CMS issued a final decision memo supporting coverage of the PRP gel, which reversed a nearly 20 year non-coverage determination for PRP (see BioCentury, Aug. 13, 2012). Cytomedix plans to begin rolling out the protocols to wound care clinics this month and expects the first patients to be treated under the protocols "soon thereafter." ...